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The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508898
Recruitment Status : Withdrawn (Funding problem; trial abandoned.)
First Posted : July 30, 2007
Last Update Posted : August 4, 2015
Information provided by:
Chinese University of Hong Kong

Brief Summary:
Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Nephritis Proteinuria Drug: Calcitriol Drug: Multivitamin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Study Start Date : May 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: treatment group
Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
Drug: Calcitriol
Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.

Active Comparator: control group
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
Drug: Multivitamin
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).

Primary Outcome Measures :
  1. change in proteinuria [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 18-65 years
  • clinical quiescent SLE for at least 12 weeks
  • baseline SLEDAI score <= 4
  • history of biopsy-proven lupus nephritis
  • estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
  • proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker for at least 3 months
  • on maintenance dose of prednisolone < 10 mg/day, with or without other immunosuppressive medications
  • corrected serum calcium level < 2.45 mmol/l
  • willingness to give written consent and comply with the study protocol

Exclusion Criteria:

  • Pregnancy, lactating or childbearing potential without effective method of birth control
  • Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
  • History of malignancy, including leukemia and lymphoma within the past 2 years
  • Systemic infection requiring therapy at study entry
  • Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
  • History of drug or alcohol abuse within past 2 years
  • Participation in any previous trial on vitamin D analogue
  • Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks. Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D.
  • On other investigational drugs within last 30 days
  • History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
  • History of non-compliance
  • Known history of sensitivity or allergy to vitamin D analogs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508898

Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Cheuk-Chun Szeto, MD Chinese University of Hong Kong

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Responsible Party: SZETO, Cheuk Chun, The Chinese University of Hong Kong Identifier: NCT00508898     History of Changes
Other Study ID Numbers: CRE-2007.261-T
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: January 2009
Keywords provided by Chinese University of Hong Kong:
lupus nephritis
chronic kidney diseases
Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents